Skip to content

NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block

NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Open Heart Surgery With Cardiopulmonary Bypass - A Propensity Matched Non-Inferiority Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06070701
Acronym
NESP-II
Enrollment
40
Registered
2023-10-06
Start date
2023-06-01
Completion date
2024-04-01
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

cardiac surgery, regional anesthesia, nociception, enhanced rehabilitation, erector spinae plane block, superficial parasternal intercostal plane block

Brief summary

This clinical trial focuses on an elaborate, propensity-matched, non-inferiority comparison of NOL-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Erector Spinae Plane Block (ESPB) within the context of open-heart surgery with cardiopulmonary bypass.

Detailed description

A. Ethics Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrollment. B. Study enrollment Forty consecutive adult patients scheduled for elective open cardiac surgery under general anesthesia are to receive general anesthesia plus SPIPB. This prospective group of patients will be matched one-to-one to a historical group of 55 patients that underwent open cardiac surgery under general anesthesia combined with ESPB. C. Methods C1. Preinduction * 16-G peripheral intravenous cannula and radial artery catheter. * Five-lead ECG, pulse oximetry, non-invasive and invasive blood pressure monitoring. * Analgesia monitor - the NoL index (PMD200TM, Medasense) finger probe will be connected to the index finger of the non-cannulated hand. * Surgical antibiotic prophylaxis (Cefuroxime 1.5g). * Stress ulcer prophylaxis (omeprazole 40 mg). C2. Superficial Parasternal Intercostal Plane Block (SPIPB) After induction, skin asepsis with chlorhexidine 2% is performed on the anterior chest wall. A high-frequency linear ultrasound probe is positioned parasagittally, 2 cm from midline, bilaterally, at the level of the 4th rib. A 25-G echogenic block needle is inserted at a 20⁰-30⁰ angle in a caudal-to-cephalad direction until the tip of the needle reaches the interfascial plane between the pectoralis major muscle and the internal intercostal muscle. Correct hydrodissection is first certified using normal saline. Subsequently, ropivacaine 0.5% with dexamethasone 8mg/20ml is used and maximum spread is attained by slowly advancing the needle as the interfascial plane splits up ahead. A maximum dose of 3mg/kg ropivacaine is used, corresponding to 1.5 mg/kg per side (e.g., 20 ml ropivacaine 0.5% / side for a 70kg adult). C3. General anaesthesia Monitoring * End tidal CO2 (ETCO2). * Bispectral index (BIS) monitoring (target 40-60). * The nociception monitor (PMD200TM, Medasense) is started before induction. * CVP insertion into the right internal jugular vein under ultrasound guidance. * Urinary catheter, rectal temperature probe placement. Induction * Propofol 1-1.5 mg/kg or Etomidate 0.2-0.3 mg/kg. * Fentanyl 5 mcg/kg. * Atracurium 0.5 mg/kg. Maintenance of anaesthesia * Sevoflurane in O2 during periods of preserved pulmonary blood flow and mechanical ventilation. * Propofol infusion during periods of extracorporeal support. * Atracurium 0.2-0.3 mg/kg/h for adequate neuromuscular blockade. Analgesia 1. Analgesic drugs * Fentanyl: bolus 1.5 mcg/kg. * Paracetamol: 1-gram following induction of general anaesthesia. 2. Analgesia monitoring * NoL index provides a multiderivative assessment of nociception before cardiopulmonary bypass (CPB) initiation. Optimal analgesia is defined as a NoL index of 10-25. * Mean arterial blood pressure (MAP) provides post-CPB decision loop: targets are within ± 15% of MAP recorded during optimum NOL. C4. Postoperative Extubation criteria * Normothermia (T◦ ≥ 36◦C). * No clinical bleeding. * Wakefulness. * Hemodynamic stability (MAP ≥ 60 mmHg and lactate ≤ 2 mmol/L) with minimal vasoactive support (dobutamine \< 5 µg/kg/min and norepinephrine \< 100 ng/kg/min). * Adequate gas exchange: * Tidal volume ≥ 5 ml/kg. * Adequate airway reflex to handle secretions. Analgesia * Paracetamol 1g iv every 6 hours. * Morphine bolus 0.03 mg/kg for NRS \> 3.

Interventions

PROCEDURESuperficial Parasternal Block (SIPB)

Immediately after induction of general anesthesia, ropivacaine 0.5% with dexamethasone 8mg/20ml (maximum dose 1.5 mg/kg ropivacaine per each side) is administered in the superficial parasternal intercostal plane using real-time ultrasound guidance.

Immediately after induction of general anesthesia, ropivacaine 0.5% with dexamethasone 8mg/20ml (maximum dose 1.5 mg/kg ropivacaine per each side) is administered in the plane deep to the erector spinae muscle, typically at the level of the 5th thoracic vertebra, under real-time ultrasound guidance.

DRUGGeneral anesthetic

During general anesthesia, fentanyl is administered according to NOL monitoring.

DRUGMorphine

Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.

Sponsors

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Propensity score matching

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Informed Consent. 2. Elective heart surgery with sternotomy and bypass. 3. Hemodynamic stability prior to induction. 4. Sinus rhythm.

Exclusion criteria

1. Known allergy to any of the medications used in the study. 2. BMI \> 35. 3. Patient refusal to participate in the study. 4. Coagulopathy (INR \> 1.5, APTT \> 45, Fibrinogen \< 150 mg/dl). 5. Non-elective/emergent and/or redo surgery. 6. ASA ≥ 4. 7. Any preoperative hemodynamic support (mechanical or pharmaceutical). 8. Severe LV dysfunction (LVEF ≤ 30%). 9. Severe RV dysfunction.

Design outcomes

Primary

MeasureTime frameDescription
Fentanyl consumption (µg/kg)during intraoperative periodIntraoperative opioid consumption after goal directed monitoring of nociception with the NOL index
Morphine consumption (µg/kg)48 hours after surgeryPostoperative opioid consumption

Secondary

MeasureTime frameDescription
Norepinephrine dose (mcg/kg)intraoperative, 6 hours and 12 hours after surgeryCumulative dose of Norepinephrine
Time to weaning-off norepinephrineup to 96 hours after surgeryFollowing ICU admission, the time it takes to stop norepinephrine administration
Dobutamine dose (mcg/kg)intraoperative, 6 hours and 12 hours after surgeryCumulative dose of Dobutamine
Quality of postoperative analgesia6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removalAssessment - numerical rating scale (NRS) (minimum of 0, maximum of 10)
Extubated patients2 hours after surgeryNumber of extubated patients after ICU admission
Norepinephrine-free patients2 hours after surgeryNumber of patients without norepinephrine support
Morphine-free patients48 hours after surgeryNumber of patients who did not require morphine rescue analgesia
Time to first dose of morphineany time for 48 hoursFollowing admission, the time it takes a patient to request morphine rescue analgesia
Time to extubationup to 24 hours after surgeryFollowing ICU admission, the time it takes to extubate the patient safely

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026